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Mesh is widely applied in the abdominal approach to pelvic organ prolapse surgery, and sacrocolpopexy-sacrohysteropexy is the gold standard application, particularly for central compartment abnormalities. There are numerous disadvantages associated with the use of mesh. In some studies, the rate of mesh complications (such as mesh erosion, contraction, response, and pain) can reach 20%. This surgical approach aims to provide laparoscopic repair of pelvic organ prolapse without the use of mesh, hence avoiding the difficulties associated with mesh.
Patients who present to the Zeynep Kamil Education and Research Hospital Gynecology and Obstetrics Clinic between July 2022 and April 2023 with the complaint of prolapse and have uterine or vaginal cuff prolapse due to a central defect or cystocele due to an anterior compartment defect and are indicated for surgery will be included in the study.The surgeries will be performed laparoscopically after obtaining their written consent.
The Technique;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meshless Approach | Experimental | Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Meshless Sacrocolpopexy Technique | Procedure | Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog Scale | Pain Scale of 0 to 10, aiming that the operation itself leaves no pain. | 6 months after the operation |
| POP-Q classification | examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur. | 6 months after the operation |
| PQOL | Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month. | 6 months after the operation |
| FSFI | Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month. | 6 months after the operation |
| Urinary Incontinance | Questioning and examining patient after surgery related to urinary incontinancy complaint, and evaluating the incontinancy state with questionnaires of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6) | 6 months after the operation |
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Inclusion Criteria:
Exclusion Criteria:
Female patients in between 30 to 80 years old with a symptomatic vaginal cuff/uterine prolapse and/or cyctocele
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Resul Karakus, MD | Contact | 05059164216 | resul-karakus@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Kamil Maternity and Childrens Training and Research Hospital | Recruiting | Istanbul | 34660 | Turkey (Türkiye) |
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Anticipated 25 patients will be evaluated and operated with meshless method.
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Only one attending surgeon will operate the all participants. The patients will be evaluated pre-operatively by the surgeon and postoperatively 6th months by a different physician ( who is practicing as a gynecologist in the same hospital).
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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